Academic Scientists Hail Supreme Court's Rejection of Gene Patents

By Goldie Blumenstyk

Washington

A unanimous U.S. Supreme Court on Thursday ruled that sequences of naturally occurring genes cannot be patented, a decision hailed by academic researchers who said it "opens up the field" for genetic testing and research.

A DNA sequence, even after it is identified and isolated, is still "a product of nature and not patent eligible," the court said in its 18-page ruling.

The ruling strikes down parts of three patents developed at the University of Utah and used by Myriad Genetics Inc. for a pricey test it sells exclusively to help predict the hereditary risk of breast and ovarian cancer. The test concerns genes known as BRCA1 and BRCA2.

"Myriad did not create or alter either the genetic information encoded in the BRCA1 and BRCA2 gene or the genetic structure of the DNA," the ruling says. "It found an important and useful gene, but groundbreaking, innovative, or even brilliant discovery does not by itself satisfy" the test for a patent, the court said, in a ruling written by Justice Clarence Thomas.

With the ruling, "the monopoly goes by the wayside," said Harry Ostrer, a professor of pathology, genetics, and pediatrics at the Albert Einstein School of Medicine. "We can now do testing."

Dr. Ostrer, who is also director of genetic and genomic testing at the Montefiore Medical Center, was among the doctors, patients, and advocates who in 2009 sued to challenge the validity of the patents after Myriad said the genetic testing he was doing on his patients infringed the company's patents.

The decision has big implications for researchers, Dr. Ostrer added. In the wake of the ruling, he said, "most isolated gene patents will probably fall by the wayside," which could pave the way for more widespread and affordable testing for genes related to sudden cardiac death and many neurological disorders.

By some estimates, the U.S. Patent and Trademark Office has issued patents covering about 20 percent of the human genome, a trend that federal health officials have called a threat to the development of genetic testing and advances in personalized medicine.

'A Rubber-Stamp Patent Office'

The case, Association for Molecular Pathology v. Myriad Genetics Inc., No. 12-398, came to the Supreme Court after a federal district court ruled against the patents and then a federal appeals court last August overturned that ruling.

The director of the National Institutes of Health, Francis S. Collins, led a round of cheering and applause when word of the court's decision reached him while he was leading a semiannual meeting of his advisory committee, in Bethesda, Md.

"What a moment," Dr. Collins exclaimed to members of the committee, a group of 18 biomedical experts, many of them prominent university leaders, after a colleague read out the decision from her phone.

Daniel B. Ravicher, executive director of the Public Patent Foundation, which brought the suit along with the American Civil Liberties Union, called the decision "a great victory for everyone, not just for our patients and scientists" but also for anyone concerned about the right to information about their own health.

"The patent office was unashamed about granting patents on our bodies until the Supreme Court told it to stop doing that," Mr. Ravicher said in an interview. "We have an out-of-control rubber-stamp patent office that only cares about making money."

Welcome News

While ruling that the act of simply isolating strands of DNA was not patentable, the court made clear that inventions based on synthetically created DNA could still be patented. Dr. Ostrer said that would be welcome news to many academic investigators "and their deans," who are eager to develop and commercialize discoveries that are "truly novel."

University of Utah officials referred all questions about the case to Myriad. On its Facebook page, the company posted a message that said in part, "The battle that really matters isn't in court; it's the one against cancer."

In a similar vein, the Association of University Technology Managers said the decision would eliminate uncertainties for commercialization. The association and a biotechnology-industry trade association had called patents on isolated DNA molecules "critical to encouraging innovation" in an earlier friend-of-the-court brief in support of Myriad. "The landscape for patents has been made clearer," said Sean Flanigan, president of the university-technology association.

Paul Basken contributed to this article.

Correction (6/17/2013, 7:11 p.m.): This article originally misstated the date of the Supreme Court's ruling. It was Thursday, June 13, not Wednesday, June 12. The article has been updated to reflect this correction.